Tracheostomy or endotracheal tubes are often placed in severely injured or ill patients to assist them in breathing. In many instances, a ventilator is connected to the tube to provide controlled ventilation.
Patients with tracheostomy tubes and ventilator circuitry are many times severely compromised and ill due to associated complications. Existing in these patients are various complications from tube movement, circuitry weight and accidental circuitry disconnections. These complications can create discomfort, skin, stoma and tracheal irritation, skin, stoma and tracheal malacia, leading to potential infections and surgical intervention, brain injury or death. The unintended pressure from the weighty and moving circuitry may result in tubing disconnection, Stoma site damage and posterior wall tracheal damage from improper tube positioning.
Tracheostomy and endotracheal tubes were customarily supported in place by a thin cotton tape extending about the neck or head of a patient. The cotton tape was typically tied to slotted flanges on either side of the tube to secure it in place. This method for securing a tracheostomy or endotracheal tube has many drawbacks. The cotton tape had to be threaded through and knotted to each flange or separate pieces had to be threaded through the flanges and then tied to each other to secure the tube. There was no convenient means for securing and/or adjusting the cotton tape to ensure a proper fit. This could result in a poorly secured or mislocated tracheostomy tube, contributing to the potential for injury of the soft tissues surrounding the stoma of a tracheostomy.
The cotton tape utilized to secure the tube also has a tendency to stretch more at the edges than at the center as it is being installed, and the tying process further distorts the tape. This results in an uneven force distribution across the width of the tape causing patient discomfort and possible skin irritation. This condition is evidenced by the typical curl at the edges of the cotton tape.
Because of the degree of intensive care required in using tracheostomy or endotracheal tubes and their accompanied tubing and circuitry, ease in maintaining the tracheostomy tube through adjustment or replacement of the retention means is also a prime concern. Not only must the retention means be easy to install and adjust, but asepsis concerns make it desirable that the retention means be low cost, soft fabric, skin friendly and therefore disposable.
U.S. Pat. No. 4,313,437 to Martin, issued Feb. 2, 1982, and U.S. Pat. No. 4,331,144 to
Wapner, issued May 25, 1982 have attempted to address some of these problems. Both show the use of a padded foam neck band and VELCRO™ fastening means. These provide easier installation, replacement and adjustment as well as more even force distribution and patient comfort. Although the tube retainer disclosed by Martin does provide for some expansion or contraction once installed, it has limited adjustability and several sizes are required for different size patients.
The support provided by Wapner involves a more complex structure. It utilizes two straps, one of which has an elastic webbing portion. This is to allow the attendant applying the band to select a comfortable pressure for securing the band to the patient. Because of its more complex structure, this support band is more costly to manufacture.
U.S. Pat. No. 5,101,822 (Kimmel), issued Apr. 7, 1992, also attempts to address these problems. Kimmel discloses a two-piece collar system which appears complex and requires the alignment of snaps on the two collar pieces and threading tapes from one collar piece through loops in the other for installation. This more complex structure could increase the cost of the device making disposable usage cost prohibitive.
U.S. Pat. No. 5,357,952 (Schuster), issued Oct. 25, 1994 addresses these problems by disclosing a collar with a complex buckle and long securement strap to retain circuitry. However, the buckle system is found to be difficult to engage and the hard , hook material used on the long strap may potentially lead to skin irritation and skin breakdown issues as well as difficulty in application of securement strap.
None of these devices provide a means for positively retaining a ventilator tube connection to the tracheostomy tube in an uncomplicated method without risking skin irritation and infection risks.